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Monday- Friday, 8a-4:30p Microbiology Analyst III - Medical Device Testing Position Summary Millstone is seeking a detail-oriented and motivated Microbiology Analyst III to join our Microbiological Medical Device Testing team. In this role, you will perform laboratory testing and evaluations on medical devices to support product development, verification, validation, quality assurance, and regulatory compliance. The ideal candidate has strong laboratory skills, experience following standardized test methods, and a commitment to producing accurate, high-quality data in a regulated environment. Key Responsibilities Perform mechanical, physical, functional, and environmental testing of medical devices according to approved protocols and standard operating procedures (SOPs). Set up, operate, calibrate, and maintain laboratory equipment and test fixtures. Execute test methods in accordance with applicable standards (ASTM, ISO, IEC, FDA, USP guidance, and internal procedures). Accurately collect, analyze, and document test data using electronic laboratory systems and approved templates. Prepare clear, complete, and technically accurate test reports. Troubleshoot test equipment, and experimental setups to resolve issues efficiently. Assist in the development, verification, and validation of new test methods and equipment. Ensure compliance with Good Documentation Practices (GDP), Good Laboratory Practices (GLP), Quality System Regulations (21 CFR Part 820), and

ISO 13485/ISO 17025

requirements. Maintain laboratory organization, inventory, and equipment maintenance records. Participate in laboratory investigations, root cause analysis, and continuous improvement initiatives. Collaborate with engineers, quality assurance, manufacturing, and regulatory teams to support project objectives. Support and provide day-to-day technical guidance to more junior laboratory colleagues by sharing best practices, assisting with laboratory techniques, and promoting adherence to laboratory procedures and quality standards. Follow all laboratory safety procedures and maintain a clean, organized work environment. Qualifications Microbiology Analyst III - Medical Device Testing Education Bachelor's in Life Sciences, Biology, Chemistry, Biomedical Engineering, or a related scientific discipline. Skills Experience operating laboratory testing equipment. Ability to read and follow technical procedures and test protocols. Strong documentation and data recording skills. Familiarity with Microsoft Office and electronic data management systems. Strong organizational and problem-solving abilities. Ability to manage multiple priorities with minimal supervision. Additional Qualifications for Microbiology Analyst III - Medical Device Testing In addition to the qualifications above: Experience 5+ years of laboratory testing experience in the microbiological medical device industry or another highly regulated environment. Technical Expertise Independently develops, modifies, and improves laboratory test methods. Leads complex testing activities and troubleshooting efforts. Performs statistical analysis and interprets technical data to identify trends and recommend improvements. Authors and reviews test protocols, reports, and technical documentation. Provides technical guidance, training, onboarding support, and mentoring to junior laboratory staff to help build technical capability and ensure consistent laboratory practices. Serves as a technical resource for laboratory personnel by answering questions, demonstrating testing techniques, and supporting the successful execution of laboratory activities. Participates in equipment qualification, validation, and laboratory process improvements. Supports audits, regulatory inspections, and quality investigations. Preferred Qualifications Experience working under

ISO 13485, ISO

17025, and FDA Quality System Regulations. Knowledge of ASTM, ISO, IEC, or USP testing standards. Experience with universal testing machines, environmental chambers, or other laboratory instrumentation. Experience supporting design verification and validation (V&V) testing. Experience with laboratory information management systems (LIMS) or electronic quality management systems (eQMS). Competencies Strong attention to detail Technical aptitude Analytical thinking Effective written and verbal communication Coaching and mentoring skills Time management and organization Collaboration and teamwork Commitment to quality and continuous improvement Ability to work independently while managing multiple priorities

Pay:

$30.00 - $34.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Experience:

Laboratory procedures: 5 years (Required)

Work Location:

In person